Disposable waterproof electrocardio acquisition equipment

Abstract

The invention discloses disposable waterproof electrocardio acquisition equipment. A shell comprises an upper cover and a lower cover; the upper cover and the lower cover are connected to form a totally-enclosed internal space, a circuit board and a disposable battery are placed in the totally-enclosed internal space, and the circuit board is provided with a metal conductive needle extending out of the lower cover; the flexible electrode patch comprises a conductive gel layer, a metal conductive layer, an insulating layer, a metal adhesion layer and a pasting layer, the metal conductive layer is provided with a signal conductive disc at each electrocardiogram sampling position, and the conductive gel layer covers each signal conductive disc; the metal wires in the insulating layer are led to one host conductive disc of the metal adhesion layer, and one host conductive disc is connected with one metal conductive needle and led into the circuit board through one metal conductive needle; two additional host conductive discs are arranged at the position of the metal adhesion layer, are connected together in a loopback mode through leads and are led into the circuit board through the other two metal conductive needles at the same time. According to the invention, the use convenience and the information and sanitation safety of the equipment are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly to a disposable waterproof electrocardiogram acquisition device. Background Art

[0002] The electrocardiogram acquisition devices commonly used in the prior art include rechargeable and reusable electrocardiogram acquisition devices and non-rechargeable single-use electrocardiogram acquisition devices. Among them, the reusable electrocardiogram acquisition device is usually used in conjunction with a disposable electrode patch. Each time it is used, the disposable electrode patch is installed on the device and then attached to the human body for recording. After the recording is completed, the device is removed to export data, and then the device is disinfected for the next use. Therefore, information and health safety problems are caused.

[0003] In order to overcome the above problems of reusable devices, single-use electrocardiogram acquisition devices have emerged. The single-use electrocardiogram acquisition device is usually assembled with the electrode patch and cannot be separated. After the data is exported after use, it can be discarded.

[0004] However, the conductive connection between the above-mentioned single-use device and the disposable electrode patch is usually a direct metal connection or an electrical connection through some flexible conductive foam. Since the conductors only contact each other and are not bonded, when the device moves, the contact interface between the conductors will shift, thereby introducing a large amount of noise into the electrocardiogram signal. In order to reduce this problem, some single-use devices insert the wire of the electrode patch into the female interface of the host through a formula interface to enhance the stability of the electrical connection. However, this design will inevitably open the shell to expose the internal female interface, thus making it impossible to be waterproof. In addition, single-use devices usually use single-use batteries and do not have a key switch. Therefore, an insulating sheet is added to the positive or negative electrode of the battery to separate the battery from the circuit to reduce the standby current of the device. However, the insulating sheet will extend out of the shell through the shell gap to facilitate the user to pull it out during use, which will also cause the shell to be unable to be waterproof, thus limiting the use scenario, especially during long-term use. Summary of the Invention

[0005] In order to overcome the deficiencies of the reusable device in the prior art, such as unstable electrical connection, information and health safety problems, and the non-waterproofness of the single-use device, the present invention provides a disposable waterproof electrocardiogram acquisition device, which improves the convenience of device use and information and health safety.

[0006] The technical solution adopted by the present invention to solve its technical problems is:

[0007] A disposable waterproof electrocardiogram (ECG) acquisition device, comprising a housing, a circuit board, a disposable battery, and a flexible electrode patch. The housing includes an upper cover and a lower cover; the upper cover and the lower cover are connected to form a fully enclosed internal space, in which the circuit board and the disposable battery are placed. The circuit board is provided with metal conductive pins extending out of the lower cover; the flexible electrode patch includes a conductive gel layer, a metal conductive layer, an insulating layer, a metal attachment layer, and an application layer. The metal conductive layer has a signal conductive disk at each ECG sampling position, and the conductive gel layer covers each signal conductive disk; it is led to a main board conductive disk of the metal attachment layer through a metal trace located in the insulating layer, and one main board conductive disk is connected to one metal conductive pin and introduced into the circuit board through a metal conductive pin; there are two additional main board conductive disks at the position of the metal attachment layer, which are connected together by a lead loop, and are respectively introduced into the circuit board by another two metal conductive pins.

[0008] Furthermore, a battery compartment is also provided on the circuit board. The circuit board realizes functions of ECG signal acquisition, storage, real-time / post-measurement uploading of local data, and patch activation detection; the disposable battery is directly installed in the battery compartment.

[0009] The disposable waterproof ECG acquisition device of the present invention does not have a physical button. When not in use, the device is in a very low power standby state. When in use, only the surface release film of the flexible electrode patch with a release film needs to be torn off, and the device can be activated without additional operations.

[0010] Still further, the housing is formed by a one-time fixed connection of the upper cover and the lower cover, and this fixed connection is an ultrasonic welding connection or a structural adhesive bonding, ensuring that water cannot enter the housing through the connection gap between the upper cover and the lower cover, that is, a waterproof connection; an opening is made in the lower cover at the position of the metal conductive pin so that the metal conductive pin extends out of the lower cover; the rest of the lower cover except the opening is bonded to the corresponding position of the flexible electrode patch through a waterproof adhesive, and the bonding material is a waterproof structural adhesive, and this bonding ensures that water cannot enter the opening position of the lower cover from the bottom of the lower cover, that is, it is also a waterproof connection.

[0011] The metal conductive pin and the main board conductive disk of the metal attachment layer are bonded by conductive silicone, and this bonding is a one-time connection.

[0012] The application layer has a surface release paper and a bottom release film. The layers of the flexible electrode patch are arranged in sequence from the human skin side as the bottom release film, the conductive gel layer, the insulating layer, the metal conductive layer, the metal attachment layer, and the surface release paper.

[0013] The base material of the application layer uses a single-sided coated PU material, and the base material is protected by a surface release paper on the side away from the human body; the coating material is a pressure-sensitive adhesive or silica gel; the side of the coating in contact with the human body is protected by a bottom release film; the surface release paper has an opening at the position of the lower cover to expose the host conductive pad on the metal attachment layer to the metal conductive needle; the surface release paper is located between the outer shell and the metal attachment layer.

[0014] The metal conductive layer is attached to the metal attachment layer, and the metal conductive layer is formed by printing or etching; the material of the metal conductive layer is silver or copper; the loop connection on the metal conductive layer protrudes outside the lower cover and is pasted on the surface release paper.

[0015] The insulating layer covers the upper and lower surfaces of all the metal attachment layers except for the signal conductive pad and the host conductive pad.

[0016] Preferably, the material of the metal attachment layer is PET or PI.

[0017] The circuit board includes an electrocardiogram (ECG) signal acquisition module, an ECG signal storage module, an ECG signal processing module, and a power supply module; the ECG signal acquisition module acquires the ECG signals of each lead formed by each electrode point and transmits them to the ECG signal processing module; the ECG signal storage module stores the ECG signals in the local memory; the ECG signal processing module performs various processes on the ECG signals, including but not limited to filtering and analog-to-digital conversion.

[0018] The ECG signal acquisition module, the ECG signal storage module, and the ECG signal processing module are all controlled by a low-power Bluetooth processor.

[0019] The ECG signal storage module uses a large-capacity memory for storage.

[0020] The ECG signal processing module receives the ECG data acquired by the ECG signal acquisition module, stores the processed data in the ECG signal storage module after data processing, and can simultaneously connect to a mobile terminal through low-power Bluetooth to transmit the ECG data in real time; the ECG signal processing module can upload all the stored data to the mobile terminal after the device is used up.

[0021] The power supply module is powered by a disposable battery; the disposable battery can be a lithium-manganese battery or a zinc-air battery.

[0022] The circuit board further includes a patch enabling detection module for detecting whether the flexible electrode patch has been enabled. The patch enabling detection module has an analog switch and a control circuit. The analog switch controls the on / off of the power supply. The control circuit detects whether the external loop connection connected to the patch enabling detection module is disconnected. If it is disconnected, the analog switch is turned on to power on the device. If it is not disconnected, the device is maintained in a low-power state. The power consumption of the control circuit is less than 1 μA.

[0023] The beneficial effects of the present invention are mainly manifested in:

[0024] 1. The main body housing and the flexible electrode patch are fixed together, and there is no need to separate them during and after use. They can be discarded after use, which improves the convenience, information, hygiene and safety of device use. Moreover, the connection between the lower cover of the housing and the flexible electrode patch is made by structural adhesive, and the upper and lower covers of the housing are connected by structural adhesive or ultrasonic welding, which can achieve an IPX7 waterproof rating for the whole machine. Furthermore, the electrical connection between the circuit board in the housing and the conductive pads of the flexible electrode patch uses silicone conductive adhesive, which improves the electrical stability of the connection and can greatly reduce the electrical noise caused by unstable connection. Moreover, when the device is powered on, only the release paper / membrane on both sides of the flexible electrode sheet needs to be torn off, and no additional power-on operations are required, such as tearing off the insulating sheet, clicking the button, etc.

[0025] 2. The flexible electrode patch includes an adhering layer and an electrode circuit layer, and the hierarchical structure is simple. During use, only the release paper / membrane needs to be torn off, and the operation is simple and convenient.

[0026] 3. The battery uses a disposable battery and is pre-installed in the battery compartment on the circuit board, which is beneficial to processing and assembly. In addition, it is located in the combined body of the sealed housing and the flexible electrode patch and is not exposed to the external environment, which can greatly improve the storage period of the battery and thus extend the shelf life of the device. Description of the Drawings

[0027] Figure 1 is the structural block diagram in the embodiment of the present invention;

[0028] Figure 2 is the block diagram of the composition of the circuit board of the present invention;

[0029] Figure 3 is the simplified diagram of the patch enabling detection circuit in the embodiment of the present invention.

[0030] Description of reference numerals: 10 - housing, 11 - upper cover, 12 - lower cover, 20 - circuit board, 21 - battery compartment, 22 - metal conductive pin, 23 - electrocardiogram signal acquisition module, 24 - electrocardiogram signal storage module, 25 - electrocardiogram signal processing module, 26 - patch activation detection module, 261 - analog switch, 262 - detection control circuit, 27 - power module, 30 - disposable battery, 40 - flexible electrode patch, 41 - conductive gel layer, 42 - metal conductive layer, 43 - insulating layer, 44 - metal adhesion layer, 45 - adherent layer, 451 - adherent layer release paper, 452 - adherent layer release film, 46 - signal conductive pad, 47 - host conductive pad, 48 - loop connection. Detailed implementation manners

[0031] The present invention will be further described below with reference to the accompanying drawings.

[0032] Refer to Figures 1 to 3 , a disposable waterproof electrocardiogram acquisition device, including a host housing 10 and a flexible electrode patch 40. The layers of the flexible electrode patch 40 are arranged in sequence from the side close to the human skin as a conductive gel layer 41, an insulating layer 43, a metal conductive layer 42, a metal adhesion layer 44, and an adherent layer 45. The metal conductive layer 42 has 3 exposed signal conductive pads 46 on the side of the flexible electrode patch 40 close to the human body, and the metal adhesion layer 44 has 5 exposed host conductive pads 47 on the side far from the human body; the housing 10 is composed of an upper cover 11 and a lower cover 12, and the upper cover 11 and the lower cover 12 are fixed together by ultrasonic welding. The lower cover 12 and the metal adhesion layer 44 of the flexible electrode patch 40 are fixedly bonded with a waterproof structural adhesive to form a complete electrocardiogram acquisition device.

[0033] The connection manner between the upper cover 11 and the lower cover 12 can also be bonding with a structural adhesive.

[0034] The interior of the housing 10 is completely isolated from the external environment to form a fully enclosed internal space. The formation of this enclosed space depends on: the upper cover 11 has no gaps, the internal connection seam between the upper cover 11 and the lower cover 12 is completely sealed by ultrasonic welding, the lower cover 12 and the metal adhesion layer 44 of the flexible electrode patch are fully adhered, and the holes on the lower cover 12 are placed in the internal space formed between the other parts of the lower cover 12 except the holes and the metal adhesion layer.

[0035] The circuit board 20 and the disposable battery 30 thereon are located in the aforementioned fully enclosed space. Since it is in a fully enclosed space, it is not affected by the high-salt and high-humidity environment of the external environment, and the shelf life of the circuit board 20 and the disposable battery 30 can be improved.

[0036] As Figure 1As shown, the conductive gel 41 covers the signal conductive disks 46 and serves as the contact interface between the human skin and the metal electrodes. The three signal conductive disks 46 of the metal conductive layer 42 and the five main body conductive disks 47 of the metal attachment layer 44 are electrically connected by wires. These wires and conductive disks are formed by printing metal paste on both sides of the metal attachment layer 44. Among them, the signal conductive disks 46 are arranged on the side of the metal attachment layer 44 close to the human body, and the specific positions are determined by the predicted electrocardiogram lead positions. The main body conductive disks 47 are arranged on the side of the metal attachment layer 44 far from the human body near the middle position, and are located directly below the housing 10. Insulating layers are covered at all wire positions of the metal conductive layer to protect the circuits. A surface release paper 451 of the sticking layer 45 is covered on the side of the metal attachment layer 44 far from the human body. The surface release paper 451 reserves an opening at the position directly below the housing 10 so that the lower cover 12 can be pasted on the metal attachment layer.

[0037] As an alternative, the metal conductive layer 42 can be formed by an etching method, or a metal preform can be pasted onto the metal attachment layer 44.

[0038] As Figure 1 shown, the combination of the metal conductive needles 22 and the circuit board 10 is pre-welded. The metal conductive needles pass through the holes reserved in the lower cover 12 and are bonded to the main body conductive disks 47 by silicone conductive glue. This method can form a complete, inseparable, and impedance-consistent signal transmission path from the signal conductive disks 46 to the electrocardiogram acquisition module 23 in the electrocardiogram transmission path, so as to minimize the change in contact impedance and thus minimize the generated contact noise.

[0039] Optionally, a non-elastic conductive glue after curing can also be used as the conductive glue.

[0040] As Figure 1 shown, there is a bottom release film 452 on the side of the sticking layer 45 close to the human body and a surface release paper 451 on the side far from the human body. The bottom release film 452 protects the glue of the sticking layer and is torn off before pasting on the human skin to expose the glue. This glue is used to paste the sticking layer on the human skin so that the device is fixed to the human body and the aforementioned conductive gel layer 41 contacts the human skin. The surface release paper 451 shapes the flexible sticking layer 45 to prevent the sticking layer 45 from being out of shape and difficult to paste on the human body after the bottom release film 452 is torn off.

[0041] As Figure 1As shown, in addition to signal acquisition, there are two additional metal conductive pins 22 on the circuit board 10. The connection of the two host conductive pads 47 connected to the conductive pins 22 on the metal conductive layer is a loop-back connection 48, that is, the two host conductive pads 47 are connected together by a wire. The part of the metal adhesion layer to which the wire adheres forms a protrusion that extends from the surface release paper 451 on the side of the application layer 45 away from the human body at the opening under the housing and is pasted on the surface release paper 451 on the side of the application layer 45 away from the human body. In this way, when using the device, after removing the surface release paper 451, this protrusion can be removed together, thereby cutting off the electrical connection between the two host conductive pads 47.

[0042] As Figure 2 shown, the circuit board 20 is composed of functional modules such as an electrocardiogram signal acquisition module 23, an electrocardiogram signal storage module 24, an electrocardiogram signal processing module 25, a patch activation detection module 26, and a power module 27. The incoming path of the human electrocardiogram signal is the human body, conductive gel 41, signal conductive pad 46, host conductive pad 47, metal conductive pin 22, and electrocardiogram signal acquisition module 23. The electrocardiogram signal is collected by the electrocardiogram acquisition module 23 and converted into a digital signal through analog-to-digital conversion and then transmitted to the electrocardiogram signal processing module 25. After the electrocardiogram signal processing module performs corresponding processing such as filtering, it is stored in the memory in the electrocardiogram signal storage module 24. In this embodiment, the main control of the circuit board integrates a processor with the Bluetooth BLE protocol.

[0043] As an alternative implementation, the Bluetooth BLE processor in this example can be changed to a processor with other wireless communication functions.

[0044] As Figure 3 shown, the patch activation detection module 26 has an analog switch 261 and a detection control circuit 262. The analog switch 261 is located between the disposable battery 30 and the circuit board 20. Whether this switch is turned off determines whether the disposable battery 30 is connected to the circuit board 20 to supply power to the circuit board 20, and a PMOS can be used. The detection control circuit 262 is connected to the aforementioned two additional metal conductive pins 22, and it determines whether the connection between these two metal conductive pins 22 is disconnected. If it is disconnected, it outputs a low level, otherwise it outputs a high level, and a resistor voltage divider device can be used. When the external loop-back connection 48 is not disconnected, the battery forms a voltage much higher than the turn-on voltage at the gate of the PMOS transistor Q1 through resistor voltage division, thereby turning off Q1, further disconnecting the battery voltage from the subsequent load. And because the resistance value used for resistor voltage division is very large, the standby power consumption of this control circuit is very small, lower than 1 μA, reaching the 100 nA level. For the commonly used disposable battery used in this control circuit, such as the CR2025 lithium manganese battery, the energy consumed in 1 year on the shelf is converted into a capacity of only 3 mAh, accounting for 2% of the total capacity, and basically does not affect the usage time of the device.

[0045] As an alternative embodiment, the analog switch and the control circuit in this embodiment can be implemented using a low-power integrated circuit.

[0046] The content described in the embodiments of this specification is only an enumeration of the implementation forms of the inventive concept and is for illustrative purposes only. The protection scope of the present invention should not be regarded as limited to the specific forms stated in this embodiment, and the protection scope of the present invention also extends to equivalent technical means that can be conceived by those of ordinary skill in the art based on the inventive concept of the present invention.

Claims

1. A disposable waterproof electrocardiogram acquisition device, characterized in that, It includes a housing (10), a circuit board (20), a disposable battery (30) and a flexible electrode patch (40). The housing (20) includes an upper cover (11) and a lower cover (12); the upper cover (11) and the lower cover (12) are connected to form a fully enclosed internal space, and the circuit board (20) and the disposable battery (30) are placed in the fully enclosed internal space. The circuit board (20) is provided with metal conductive pins (22) extending out of the lower cover (12); the flexible electrode patch (40) includes a conductive gel layer (41), a metal conductive layer (42), an insulating layer (43), a metal adhesion layer (44) and an application layer (45). The metal conductive layer (42) has a signal conductive disk (46) at each electrocardiogram sampling position, and the conductive gel layer (41) covers each signal conductive disk (46); it is led to a main machine conductive disk (47) of the metal adhesion layer (44) through a metal trace located in the insulating layer (43). One main machine conductive disk (47) is connected to one metal conductive pin (22) and introduced into the circuit board (20) through one metal conductive pin (22); there are two additional main machine conductive disks (47) at the position of the metal adhesion layer (44), which are connected together through a lead loop connection (48) and are respectively introduced into the circuit board (20) by the other two metal conductive pins (22).

2. The disposable waterproof electrocardiogram acquisition device according to claim 1, wherein, A battery compartment (21) is also provided on the circuit board (20). The circuit board (20) realizes functions of electrocardiogram signal acquisition, storage, real-time / post-test uploading of local data and patch activation detection; the disposable battery (30) is directly installed in the battery compartment (21).

3. The disposable waterproof electrocardiogram acquisition device according to claim 1 or 2, characterized in that, The housing (10) is fixedly connected by the upper cover (11) and the lower cover (12) at one time, and this fixed connection is an ultrasonic welding connection or a structural adhesive bonding, ensuring that water cannot enter the housing (10) from the connection gap between the upper cover (11) and the lower cover (12), that is, it is a waterproof connection; an opening is made at the position of the metal conductive pin (22) in the lower cover (12) so that the metal conductive pin (22) extends out of the lower cover (12); the rest of the lower cover (12) except the opening is bonded to the corresponding position of the flexible electrode sheet through a waterproof adhesive, and the bonding material is a waterproof structural adhesive, and this bonding ensures that water cannot enter the opening position of the lower cover (12) from the bottom of the lower cover (12), that is, it is also a waterproof connection.

4. A disposable waterproof electrocardiogram acquisition device according to claim 1 or 2, characterized in that, The metal conductive pin (22) and the main machine conductive disk (47) of the metal adhesion layer (44) are bonded by conductive silicone, and this bonding is a one-time connection.

5. The disposable waterproof electrocardiogram acquisition device according to claim 1 or 2, characterized in that, The application layer (45) has a surface release paper (451) and a bottom release film (452). The layers of the flexible electrode patch (40) are arranged in sequence from the human skin side as the bottom release film (452), the conductive gel layer (41), the insulating layer (43), the metal conductive layer (42), the metal adhesion layer (44) and the surface release paper (451).

6. The disposable waterproof electrocardiogram acquisition device according to claim 5, wherein, The substrate of the application layer (45) is made of a single-sided coated PU material. The glue is coated on the side close to the human body, and there is a surface release paper (451) on the side of the substrate away from the human body to protect the substrate; the material of the glue is pressure-sensitive adhesive or silicone; the side of the glue close to the human body is protected by a bottom release film (452); the surface release paper (451) is perforated at the position of the lower cover (12) to expose the main body conductive pad (47) located on the metal attachment layer (44) to the metal conductive needle (22); the surface release paper (451) is located between the outer shell (10) and the metal attachment layer (44).

7. The disposable waterproof electrocardiogram acquisition device according to claim 1 or 2, characterized in that, The metal conductive layer (42) is attached to the metal attachment layer (44), and the metal conductive layer (42) is formed by printing or etching; the material of the metal conductive layer (42) is silver or copper; the loop connection (48) on the metal conductive layer (42) protrudes outside the lower cover (12) and is pasted on the surface release paper (451).

8. The disposable waterproof electrocardiogram acquisition device according to claim 1 or 2, characterized in that, The insulating layer (43) covers the upper and lower surfaces of all the metal attachment layer (44) except for the signal conductive pad (46) and the main body conductive pad (47).

9. The disposable waterproof electrocardiogram acquisition device according to claim 1 or 2, characterized in that The circuit board (20) includes an electrocardiogram signal acquisition module (23), an electrocardiogram signal storage module (24), an electrocardiogram signal processing module (25) and a power supply module (27); the electrocardiogram signal acquisition module acquires the electrocardiogram signals of each lead formed by each electrode point and transmits them to the electrocardiogram signal processing module; the electrocardiogram signal storage module stores the electrocardiogram signals in the local memory; the electrocardiogram signal processing module performs various processes on the electrocardiogram signals, including but not limited to filtering and analog-to-digital conversion.

10. A disposable waterproof electrocardiogram acquisition device according to claim 9, characterized in that, The circuit board (20) further includes a patch enabling detection module (26), and the patch enabling detection module (26) has an analog switch (261) and a control circuit (262); the analog switch (261) controls the on and off of the power supply; the control circuit (262) detects whether the external loop connection (48) connected to the patch enabling detection module is disconnected. If it is disconnected, the analog switch (261) is turned on to power on the device. If it is not disconnected, the device is maintained in a low power consumption state.

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